Ranbaxy holds breath as FDA scrutinises corrective action plan

The US Food and Drug Administration (FDA) is reviewing a corrective action plan submitted by  Ranbaxy Laboratories Ltd, controlled by Tokyo-based Daiichi Sankyo Co. Ltd,  after some medicines manufactured at its plants in India were barred from being exported to the US.

FDA has not revealed what the plan entails.

''The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the U.S. market are safe and effective,'' FDA spokesman Christopher Kelly said in an e-mail to news agencies yesterday.

A ban in the US, the world's largest drug market, will have a serious effect on Ranbaxy's balance sheet, analysts opined. (See: FDA woes hit Ranbaxy in Q4 ).  

''The next steps will be dependent on the actions identified'' in the plan, Kelly said.

The FDA had in September blocked the import of 30 medicines produced at two of Ranbax's plants  citing Ranbaxy had falsified data from the factory in Paonta Sahib. (See: Ranbaxy plant in India falsified data: US FDA).

However, drugs from that plant were approved for sale in the UK and Australia after a joint audit by regulators, Ranbaxy said in March.

Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995.

The generic giant had been in the eye of storm several times. Last year, US prosecutors filed a motion in federal court in Maryland alleging that Ranbaxy forged documents relating to an investigation into the quality of the company's drugs sold in the US.

The company was also alleged to have involved in distributing adulterated HIV drugs that were given to thousands of AIDS patients in Africa. However, Ranbaxy always refuted these charges. (See: Ranbaxy denies allegation of substandard drug sale; gets nod for stake sale).

However, investors are not concerned about the FDA interventions. Ranbaxy's stock  rose 4.24 per cent to Rs272.95 at close in Mumbai trading on Friday.

Atul Sobti, who replaced Malvinder Singh as CEO last week, said Ranbaxy expects the full approval process by the FDA to take months. (See: Malvinder Singh relinquishes charge of Ranbaxy; Daiichi takes over)